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Acetaminophen Oral Solution USP - Major


Active ingredient(s)

(in each 5 mL teaspoonful)

Acetaminophen 160 mg 


Purpose

Pain reliever/fever reducer


Use(s)

temporarily relieves minor aches and pains due to:

temporarily reduces fever

  •  headache
  •  muscular aches
  •  backache
  •  minor pain of arthritis
  •  the common cold
  •  toothache
  •  premenstrual and menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

Allergy alert: Acetaminophen may cause severe skin reactions.  Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  •  adult takes more than 6 doses in 24 hours, which is the maximum daily amount

Do not use

Ask a doctor before use if the user has  liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

  • with any other drug containing acetaminophen (prescription or nonprescription).

Stop use and ask a doctor if

  • symptoms do not improve

If pregnant or breast-feeding,

ask a health professional before use.


Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.

(1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.


Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.


Directions

agedose
adults and children 12 years of age and over20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age7.5 mL (240 mg) every 4 hoursnot to exceed 5 doses in a 24-hour period
children 2 to under 4 years of age5 mL (160 mg) every 4 hoursnot to exceed 5 doses in a 24-hour period
children under 2 years of ageconsult a doctor
  •  do not take more than directed (see overdose warning)

Other information

NDC 0904-7319-41: 5 mL unit dose cup, in a tray of ten cups.

NDC 0904-7320-02: 10.15 mL unit dose cup, in a tray of ten cups.

NDC 0904-7321-03: 20.3 mL unit dose cup, in a tray of ten cups.

  •  Each 5 mL contains:  sodium 2 mg
  •  store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
  •  keep tightly closed  ■ protect from light
  •  a red, cherry flavored solution supplied in the following oral dosage forms:

Inactive ingredients

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.


Distributed by:

MAJOR® PHARMACEUTICALSIndianapolis, IN 46268